Mass Balance Study of [14C]DA-302168S in Healthy Chinese Adult Male Participants

- Male participants aged 18-55 years inclusive at ICF signing.

At screening, weight ≥50.0 kg and BMI 19.0-28.0 kg/m² inclusive.

Male participants must agree to use reliable contraception for themselves and their partners during the study and for 1 year after dosing (see Appendix 2), and not donate sperm for assisted reproduction.

Able to understand the study procedures and methods, voluntarily sign the ICF, and willing to strictly comply with the protocol and complete the study.

Detailed medical history, physical examination, vital signs, laboratory tests [CBC, blood chemistry, coagulation, urinalysis, stool routine and occult blood, thyroid function (FT3, FT4, TSH), HbA1c, amylase, lipase, serum calcitonin], 12-lead ECG, chest X-ray (PA), digital rectal examination, and abdominal ultrasound (liver, gallbladder, pancreas, spleen, both kidneys) show no abnormalities or no clinically significant abnormalities.

Exclusion Criteria:

• History or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or MEN2; or serum calcitonin ≥50 ng/L at screening.

History of chronic pancreatitis, or acute pancreatitis within 3 months before ICF signing.

History of acute gallbladder disease within 3 months before ICF signing.

Any malignancy within 5 years before ICF signing (except basal cell carcinoma treated with curative therapy and considered cured).

History of serious cardiovascular, neuropsychiatric, gastrointestinal, respiratory, urinary, or endocrine disease within 1 year before ICF signing (e.g., acute myocardial infarction, major depression, gastric ulcer, uremia).

As judged by the investigator, dysphagia at screening, or concurrent conditions that may affect drug absorption, distribution, metabolism, or excretion, such as active inflammatory bowel disease, gastrectomy, or any intestinal resection.

Severe hypoglycemia within 3 months before screening.

History of allergic diseases (e.g., asthma, urticaria, eczematous dermatitis), or known intolerance or allergy to GLP-1R agonists.

Hemorrhoids, or perianal disease with regular/current hematochezia, irritable bowel syndrome, or inflammatory bowel disease.

Habitual constipation or diarrhea.

Blood donation or major bleeding (≥400 mL) within 3 months before screening, or between screening and first dose.

History of drug abuse within 3 years before screening (e.g., morphine, ketamine, THC acid, methamphetamine, MDA, cocaine), or positive urine drug test at screening (D-2).

Smoking >5 cigarettes/day or habitual use of nicotine-containing products within 3 months before screening, and unable to abstain during the study.

History of alcohol abuse within 1 year before screening (male: >14 standard units/week; 1 unit = 14 g alcohol, e.g., 360 mL beer, 45 mL 40% spirits, or 150 mL wine), or positive alcohol breath/blood test at screening.

Special dietary requirements and unable to accept the standardized diet.

Habitual intake of grapefruit juice or excessive tea, coffee, and/or caffeinated beverages (>8 cups, 1 cup = 250 mL) within 3 months before screening, and unable to abstain during the study.

Unable to avoid strenuous exercise or other behaviors that may affect PK parameters from 48 h before dosing through the entire study.

History of needle or blood phobia, difficult blood collection, or intolerance to venipuncture.

Use of any medication within 28 days or 5 elimination half-lives before first dose, whichever is longer, including prescription drugs, OTC drugs, herbal medicines, Chinese patent medicines, or nutritional supplements.

Live vaccination within 1 month before screening, or planned vaccination during the study.

Participation in any clinical trial within 3 months before screening (except ICF signing only without drug/device intervention), or last dose of investigational drug \<5 half-lives before screening.

Occupational long-term radiation exposure; or significant radiation exposure within 1 year before the study (e.g., ≥2 chest/abdominal CT scans or ≥3 other types of X-ray examinations); or planned radiological diagnosis/treatment within 1 year after the study; or participation in a clinical trial involving radiolabeled drugs within 1 year.

Any other condition that, in the investigator's opinion, makes the participant unsuitable for the trial.